FDA Approves First Condom for Anal Sex

To try to gather data that could lead to the approval of condoms for anal sex, the company teamed up with researchers at Emory University, met with the FDA, and devised a study.

The largest study to date on condom effectiveness during anal sex, funded by the National Institutes of Health, was conducted between May 2016 and May 2017. It included 504 men, half of whom had sex with men and half with men. Dr. Siegler said women and researchers took several steps designed to encourage more consistent and accurate data from previous studies.

After being trained in the correct use of condoms, the men were given condoms and asked to fill out a daily diary on a phone app, answering questions about whether they had sex that day and whether the condom they were using broke. Participants reported 2,351 acts of anal and 2,533 vaginal sex during the study period.

Dr. Siegler said the team assumed the condom failure rate during anal sex would be low enough to pass the FDA, but didn’t expect it to be that low — 0.7 percent — or lower. more than the failure rate during vaginal sex, which was 1.9 percent.

The researchers attributed the higher failure rate during vaginal sex, with the study encouraging the use of “lubricant” only during vaginal sex, adhering to public health guidelines, for each case of anal sex. necessary or desired.”

That is, 98 percent of those who had anal sex used lubricant, while only 42 percent of those who had vaginal sex did. When researchers looked at people who only used lubricants, the failure rate in the vaginal group was 1.1 percent, making the probability of failure in each group basically the same, the study reported.

Public health experts said they suggested the lubricant was critical to the results of the study, and the FDA said in a statement that the condom “must be used with a condom-compatible lubricant” during anal sex.

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